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| Name | Class |
|---|---|
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
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This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, â…¡ A2 or IIB with tumor size> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant chemotherapy group | Experimental | Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy. Risk factors: (1) Deep cervical invasion(≥ 2/3);(2)Differentiation grade 2-3;(3)Lymphatic vascular space infiltration;(4)Adenocarcinoma or adenosquamous carcinoma;(5)Tumor size ≥ 4cm before surgery. |
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| Control group | No Intervention | The participants receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant chemotherapy | Drug | Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2, 30min + Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first. | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from the date of randomization until death of any cause. | 5 year |
| Quality of Life Outcomes | Patients are asked to complete the questionnaire EORTC QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ding Ma, M.D., PhD | Contact | 0086-27-83662681 | dma@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
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| First Affiliated Hospital of Chongqing Medical University |
| OTHER |
| Hunan Cancer Hospital | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
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| 5 years |
| Quality of Life Outcomes of cervical cancer | Patients are asked to complete the questionnaire EORTC QLQ-CX24 | 5 years |
| Incidence of Toxicity | The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0. | 5 years |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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